30day FRN

79630

Federal Register / Vol. 89, No. 189 / Monday, September 30, 2024 / Notices

DEPARTMENT OF HEALTH AND
HUMAN SERVICES

DEPARTMENT OF HEALTH AND
HUMAN SERVICES

National Institutes of Health

National Institutes of Health

National Institute of Allergy and
Infectious Diseases; Notice of Closed
Meeting

Submission for OMB Review; 30-Day
Comment Request Investigational
Agent Accountability Record Forms
and International Investigator
Statement in the Conduct of
Investigational Trials for the Treatment
of Cancer (National Cancer Institute)

Pursuant to section 1009 of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute of
Allergy and Infectious Diseases Special
Emphasis Panel; NIAID SBIR Phase II
Clinical Trial Implementation Cooperative
Agreement (U44 Clinical Trial Required).
Date: October 24, 2024.
Time: 12:00 p.m. to 2:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institute of Allergy and
Infectious Diseases, National Institutes of
Health, 5601 Fishers Lane, Room 3F40A,
Rockville, MD 20892 (Video Assisted
Meeting).
Contact Person: Robert C. Unfer, Ph.D.,
Scientific Review Officer, Scientific Review
Program, Division of Extramural Activities,
National Institute of Allergy and Infectious
Diseases, National Institutes of Health, 5601
Fishers Lane, Room 3F40A, Rockville, MD
20892, (240) 669–5035, [email protected].
(Catalogue of Federal Domestic Assistance
Program Nos. 93.855, Allergy, Immunology,
and Transplantation Research; 93.856,
Microbiology and Infectious Diseases
Research, National Institutes of Health, HHS)
Dated: September 25, 2024.
Lauren A. Fleck,
Program Analyst, Office of Federal Advisory
Committee Policy.

ddrumheller on DSK120RN23PROD with NOTICES1

[FR Doc. 2024–22377 Filed 9–27–24; 8:45 am]
BILLING CODE 4140–01–P

AGENCY:

National Institutes of Health,

HHS.
ACTION:

Notice.

In compliance with the
Paperwork Reduction Act of 1995, the
National Institutes of Health (NIH) has
submitted to the Office of Management
and Budget (OMB) a request for review
and approval of the information
collection listed below.
DATES: Comments regarding this
information collection are best assured
of having their full effect if received
within 30 days of the date of this
publication.
SUMMARY:

Written comments and
recommendations for the proposed
information collection should be sent
within 30 days of publication of this
notice to www.reginfo.gov/public/do/
PRAMain. Find this particular
information collection by selecting
‘‘Currently under 30-day Review—Open
for Public Comments’’ or by using the
search function.
FOR FURTHER INFORMATION CONTACT: To
request more information on the
proposed project or to obtain a copy of
the data collection plans and
instruments, contact Charles Hall, Chief,
Pharmaceutical Management Branch,
Cancer Therapy Evaluation Program,
Division of Cancer Diagnosis and
Treatment, National Cancer Institute,
9609 Medical Center Drive, Bethesda,
Maryland 20892 or call non-toll-free
number (240) 276–6575 or Email your
request, including your address to:
[email protected].
SUPPLEMENTARY INFORMATION: This
proposed information collection was
previously published in the Federal
Register on July 12, 2024 (89 FR 57157)
and allowed 60 days for public
comment. No public comments were
received. The purpose of this notice is
ADDRESSES:

to allow an additional 30 days for public
comment. The National Cancer Institute
(NCI), National Institutes of Health, may
not conduct or sponsor, and the
respondent is not required to respond
to, an information collection that has
been extended, revised, or implemented
on or after October 1, 1995, unless it
displays a currently valid OMB control
number.
In compliance with Section
3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the National
Institutes of Health (NIH) has submitted
to the Office of Management and Budget
(OMB) a request for review and
approval of the information collection
listed below.
Proposed Collection: Investigational
Agent Accountability Record Forms and
International Investigator Statement in
the Conduct of Investigational Trials for
the Treatment of Cancer (National
Cancer Institute), 0925–0613, Expiration
Date 1/31/2025, REVISION, National
Cancer Institute (NCI), National
Institutes of Health (NIH).
Need and Use of Information
Collection: The Food and Drug
Administration (FDA) requires
Investigational New Drug Application
(IND) sponsors to maintain adequate
records on the shipment and disposition
of agents to investigators. The agent
accountability effort for the National
Cancer Institute/Division of Cancer
Treatment and Diagnosis/Cancer
Therapy Evaluation Program (NCI/
DCTD/CTEP) is managed by the
Pharmaceutical Management Branch
(PMB) at CTEP. The Investigational
Agent Accountability Records (a.k.a.
Drug Accountability Record Forms—
DARF) are used to provide a
standardized method of tracking agent
disposition across all institutions
participating in trials for which the NCI
provides agents. Institutional auditors
verify information on the agent
accountability forms for compliance. In
addition, PMB staff review
Investigational Agent Accountability
Record Forms against records
maintained in PMB systems to ensure
there is no inappropriate use or
diversion of investigational agents.
OMB approval is requested for 3
years. Respondents’ only cost is their
time. The total estimated annualized
burden is 4,166 hours.

ESTIMATED ANNUALIZED BURDEN HOURS
Category of
respondent

Form name
A1: Investigational Agent Accountability Record Form
(DARF).

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1,000

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Average time
per response
(in hours)

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4/60

Total annual
burden hours

I

1,333

79631

Federal Register / Vol. 89, No. 189 / Monday, September 30, 2024 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS—Continued

A2: Investigational Agent Accountability Record for Oral
Agents Form (DARF-Oral).
A3: Electronic Agent Accountability Record Form
(eDARF).

Individuals ........

1,500

20

4/60

2,000

Individuals .........

2,500

20

1/60

833

Totals .......................................................................

...........................

5,000

100,000

........................

4,166

[FR Doc. 2024–22383 Filed 9–27–24; 8:45 am]
BILLING CODE 4140–01–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Dental &
Craniofacial Research; Notice of
Closed Meetings
Pursuant to section 1009 of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.

ddrumheller on DSK120RN23PROD with NOTICES1

Average time
per response
(in hours)

Category of
respondent

Dated: September 25, 2024.
Diane Kreinbrink,
Project Clearance Liaison, National Cancer
Institute, National Institutes of Health.

Name of Committee: National Institute of
Dental and Craniofacial Research Special
Emphasis Panel; Small Research Grants (R03)
for New Investigators and Secondary Data
Analysis PARs Review.
Date: November 6–7, 2024.
Time: 9:00 a.m. to 12:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institute of Dental &
Craniofacial Research, 31 Center Drive,
Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Thomas John O’Farrell,
Ph.D., Scientific Review Officer, Scientific
Review Branch, Division of Extramural
Activities, National Institute of Dental and
Craniofacial Research, 31 Center Drive,
Bethesda, MD 20892, (301) 584–4859, email:
[email protected].
Name of Committee: National Institute of
Dental and Craniofacial Research Special
Emphasis Panel; Assessment of Climate at
Institutions (ACt) Award (RC2—Clinical Trial
Not Allowed).

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respondents

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respondent

Form name

Date: November 8, 2024.
Time: 10:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institute of Dental &
Craniofacial Research, 31 Center Drive,
Bethesda, MD 20892 Virtual Meeting).
Contact Person: Christopher Campbell,
Ph.D., MD, Scientific Review Officer,
Scientific Review Branch, Division of
Extramural Activities, National Institute of
Dental and Craniofacial Research, 31 Center
Drive, Bethesda, MD 20892, (301) 827–4603,
email: [email protected].
Name of Committee: National Institute of
Dental and Craniofacial Research Special
Emphasis Panel; Prospective Observational
or Biomarker Validation Study Cooperative
Agreement.
Date: November 12, 2024.
Time: 3:00 p.m. to 4:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institute of Dental &
Craniofacial Research, 31 Center Drive,
Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Christopher Campbell,
Ph.D., MD, Scientific Review Officer,
Scientific Review Branch, Division of
Extramural Activities, National Institute of
Dental and Craniofacial Research, 31 Center
Drive, Bethesda, MD 20892, (301) 827–4603,
email: [email protected].
(Catalogue of Federal Domestic Assistance
Program No. 93.121, Oral Diseases and
Disorders Research, National Institutes of
Health, HHS)
Dated: September 25, 2024.
Bruce A. George,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2024–22371 Filed 9–27–24; 8:45 am]
BILLING CODE 4140–01–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Eunice Kennedy Shriver National
Institute of Child Health & Human
Development; Amended Notice of
Meeting
Notice is hereby given of a change in
the meeting of the Eunice Kennedy
Shriver National Institute of Child
Health and Human Development

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Special Emphasis Panel, Optimizing
Outcomes of Children and Adolescents
with Perinatal HIV Exposure (U19),
November 07, 2024, 09:00 a.m. to 05:00
p.m., 6710 B Rockledge Drive, Bethesda,
MD 20892 which was published in the
Federal Register on August 28, 2024, FR
Doc. No. 2024–19290, 89 FR 68911.
This notice is being amended to
change the meeting from a one-day
meeting on November 7, 2024, 9:00 a.m.
to 5:00 p.m., to a two-day meeting
starting on November 7, 2024, 9:00 a.m.
to November 8, 2024, 5:00 p.m. The
meeting is closed to the public.
Dated: September 25, 2024.
Lauren A. Fleck,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2024–22375 Filed 9–27–24; 8:45 am]
BILLING CODE 4140–01–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute on Aging; Notice of
Closed Meeting
Pursuant to section 1009 of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute on
Aging Special Emphasis Panel; Dog Aging
Project.
Date: November 6, 2024.
Time: 12:00 p.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.

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